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Completed

NCT Number: NCT04986969

Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Cardiac Disease

Individuals with heart disease and depressive symptoms suffer from higher death rates, higher rates of acute cardiac events (such as heart attacks), and faster progression of heart disease compared to those with heart disease who do not have depressive symptoms, and these problems are much worse in rural people. Unfortunately, rural people with heart disease and depressive symptoms do not receive needed therapy for depressive symptoms because of lack of mental health providers in rural areas, worries about stigma, and difficulty accessing mental health care because of multiple barriers to traveling to get care. To overcome these barriers, the investigators will compare the impact of two types of online cognitive behavioral therapy (video-conferenced face-to-face versus self-administered internet-based) and usual care on depressive symptoms to provide patients and healthcare providers with needed information about which is more effective and to increase the number of patients adequately treated.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Cardiovascular Diseases Depression Heart Diseases

Age range

21 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

Rural areas are noted for marked disparities in mortality, cardiovascular health, and access to health care. Prevalence rates for both coronary heart disease (CHD) and depressive symptoms in rural areas are higher than in urban areas. These facts are important because CHD patients experience high rates of depressive symptoms, which are associated with increased risk of getting and dying from CHD. Unfortunately, rural people with CHD and depressive symptoms do not receive needed therapy for depressive symptoms because of lack of mental health providers in rural areas, worries about stigma leading to treatment avoidance, and difficulty accessing mental health care because of barriers to travel to get care. Cognitive behavioral therapy (CBT), reduces depressive symptoms in CHD patients, but in its traditional form (in-person meetings of patient and therapist), CBT is resource-intensive and inaccessible to most rural patients. Wireless internet technology has the potential to make CBT more user-friendly, and accessible to rural patients. There has been a proliferation of alternative, internet-based, remote-delivery CBT interventions recently. The permutations of remote-delivery CBT fall under two categories - real-time, face-to-face, video-conferenced CBT (vcCBT) and self-administered internet-based CBT (iCBT). It is unclear which category of these delivery modalities is more effective. Determining which treatment option is more effective for treating depressive symptoms in rural patients with CHD and depressive symptoms will identify an easily accessible treatment option for rural patients. Using a randomized, controlled, stratified (by sex) design, the investigators will compare vcCBT, iCBT and usual care in rural CHD patients on the primary outcome of depressive symptoms over time. In addition, the investigators will determine whether intervention adherence, satisfaction or acceptability moderate treatment effects. The investigators will also assess whether sex or stigma moderate intervention effects to determine whether effectiveness of treatment option varies by sex or stigma level. Data about outcomes will be collected at baseline, 3 months, 6 months, and 12 months and provide important information about the trajectory of outcomes. Results from this study will provide new knowledge about which approach to treating depressive symptoms in rural CHD patients is more effective to improve decision-making in patients and healthcare providers, and increase the number of patients properly treated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least moderate depressive symptoms (PHQ-9 ≥ 10)
  • rural dwelling
  • has had physician-documented acute coronary syndrome (ACS) event

Exclusion criteria

  • cognitive impairment
  • major psychiatric comorbidities, which might require additional treatment
  • presence of non-CHD conditions likely to be fatal within next year.

Treatment and study plan

Online Cognitive Behavioral Therapy

Behavioral

online cognitive behavioral therapy delivered using one of two active methods

Primary outcomes

  1. Change in depressive symptoms as a result of intervention effects

    Time frame: Baseline, 3, 6 and 12 months

    Change in levels of depressive symptoms measured using the Patient Health Questionnaire-9, across time and between subjects. The Patient Health Questionnaire-9 is a measure that consists of nine items that correspond to criteria for diagnosing depression. Higher scores indicate greater severity of symptoms. Scores on measure can range from 0-27 with an accepted cut-off of ≥ 10 for moderate symptoms. Reliability and validity of the instrument have been established in a variety of populations, including cardiac patients.

  2. Change in intervention effects on depressive symptoms moderated by perceived stigma

    Time frame: Baseline, 3, 6, and 12 months

    The investigators will determine whether perceived stigma moderates intervention effects on depressive symptoms across time. Stigma refers to negative beliefs about a condition and its treatment. Depression-related stigma will be measured using the Depression Stigma Scale. Developed to measure personal stigma related to being treated for depressive symptoms, the measure has been used extensively since its inception. Scores on the 18-item total scale can range from 0-36, and higher scores indicate greater perceptions of stigma. The instrument has well-established reliability and validity, and has been used in rural Kentuckians.

  3. Change in intervention effects on depressive symptoms moderated by sex

    Time frame: Baseline, 3, 6, and 12 months

    The investigators will determine whether sex moderates intervention effects on depressive symptoms across time. Sex will be self-described by the patient.

Secondary outcomes

  1. Change in intervention effects on depressive symptoms moderated by health literacy

    Time frame: Baseline, 3, 6, and 12 months

    Determine whether health literacy measured using the Newest Vital Sign moderates intervention effects on change in depressive symptoms. Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. The investigator will assess health literacy using the Newest Vital Sign. This instrument is sensitive, reliable and valid for the assessment of health literacy, and is well-accepted by individuals being screened even when they have low educational level.

  2. Compare all-cause hospitalization rates between intervention groups

    Time frame: 3 months

    Measurement of hospitalization rates using the electronic health record and patient interview

  3. Compare all-cause hospitalization rates between intervention groups

    Time frame: 6 months

    Measurement of hospitalization rates using the electronic health record and patient interview

  4. Compare all-cause hospitalization rates between intervention groups

    Time frame: 12 months

    Measurement of hospitalization rates using the electronic health record and patient interview

  5. Compare physical activity levels between groups

    Time frame: 3 months

    Measurement of physical activity levels using actigraphy. Actigraphy is an objective method of obtaining accurate and reproducible activity levels, and advances in the technology have produced an instrument that reliably and validly represents physical activity levels. The investigators use the GT9X-BT Link Bluetooth Activity Monitor (ActiGraph, Pensacola, FL). The Actigraph is an omni-directional accelerometer, which assesses acceleration in multiple directions as opposed to uniaxial accelerometer, which is sensitive to movement only in the vertical axis. The actigraph has a dynamic range of ± 8 g. The Actigraph allows researchers to estimate energy expenditure by quantifying the amount time spent in light [<3 metabolic equivalents (METs)], moderate (3-5.99 METs), and vigorous (≥6 METs) physical activity.

  6. Compare physical activity levels between groups

    Time frame: 6 months

    Measurement of physical activity levels using actigraphy. Actigraphy is an objective method of obtaining accurate and reproducible activity levels, and advances in the technology have produced an instrument that reliably and validly represents physical activity levels. The investigators use the GT9X-BT Link Bluetooth Activity Monitor (ActiGraph, Pensacola, FL). The Actigraph is an omni-directional accelerometer, which assesses acceleration in multiple directions as opposed to uniaxial accelerometer, which is sensitive to movement only in the vertical axis. The actigraph has a dynamic range of ± 8 g. The Actigraph allows researchers to estimate energy expenditure by quantifying the amount time spent in light [<3 metabolic equivalents (METs)], moderate (3-5.99 METs), and vigorous (≥6 METs) physical activity.

  7. Compare physical activity levels between groups

    Time frame: 12 months

    Measurement of physical activity levels using actigraphy. Actigraphy is an objective method of obtaining accurate and reproducible activity levels, and advances in the technology have produced an instrument that reliably and validly represents physical activity levels. The investigators use the GT9X-BT Link Bluetooth Activity Monitor (ActiGraph, Pensacola, FL). The Actigraph is an omni-directional accelerometer, which assesses acceleration in multiple directions as opposed to uniaxial accelerometer, which is sensitive to movement only in the vertical axis. The actigraph has a dynamic range of ± 8 g. The Actigraph allows researchers to estimate energy expenditure by quantifying the amount time spent in light [<3 metabolic equivalents (METs)], moderate (3-5.99 METs), and vigorous (≥6 METs) physical activity.

  8. Compare medication adherence between groups

    Time frame: 3 months

    Measurement of medication adherence will be done using the Medication Event Monitoring System. Medication adherence will be measured with the Medication Event Monitoring System (MEMS; AARDEX, Union City, CA), a reliable, accurate and objective method. The MEMS is considered the gold standard in medication adherence measurement. The MEMS offers the advantage of objective measurement and has been successfully used in multiple clinical trials by our group.

  9. Compare medication adherence between groups

    Time frame: 6 months

    Measurement of medication adherence will be done using the Medication Event Monitoring System. Medication adherence will be measured with the Medication Event Monitoring System (MEMS; AARDEX, Union City, CA), a reliable, accurate and objective method. The MEMS is considered the gold standard in medication adherence measurement. The MEMS offers the advantage of objective measurement and has been successfully used in multiple clinical trials by our group.

  10. Compare medication adherence between groups

    Time frame: 12 months

    Measurement of medication adherence will be done using the Medication Event Monitoring System. Medication adherence will be measured with the Medication Event Monitoring System (MEMS; AARDEX, Union City, CA), a reliable, accurate and objective method. The MEMS is considered the gold standard in medication adherence measurement. The MEMS offers the advantage of objective measurement and has been successfully used in multiple clinical trials by our group.

  11. Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety

    Time frame: Baseline

    Measured using interviews for dietary recall

  12. Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety

    Time frame: 3 months

    Measured using interviews for dietary recall

  13. Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety

    Time frame: 6 months

    Measured using interviews for dietary recall

  14. Compare the effect of intervention effects on within-meal, across meal, and within-food group diet variety

    Time frame: 12 months

    Measured using interviews for dietary recall

Sponsors and collaborators

Lead sponsor

Debra Moser

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • University of California, Los Angeles

Registry information

Official study title

Online Cognitive Behavioral Therapy for Depressive Symptoms in Rural Patients with Coronary Heart Disease

Acronym: COMBAT-DS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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